Having hit in phase III, Hutchison China Meditech’s colorectal cancer asset fruquintinib looks like a good bet for approval in China. But it could be a bigger win than that for the company: Chi-Med has previously said that success with fruquintinib would prove the utility of its kinase inhibitor platform.
Topline results from the Fresco study showed that the VEGFR inhibitor increased overall survival over placebo when used in the third-line setting. Attention will now turn to the company’s other TKIs, including the c-Met inhibitor savolitinib, which unlike the China-focused fruquintinib could go global.
Fresco signed up 416 patients with locally advanced or metastatic colorectal cancer, who had failed at least two prior chemotherapies. Chi-Med called the overall survival improvement “clinically meaningful and statistically significant” in the intent-to-treat population, and said the study hit on progression-free survival too, with no red flags on safety. The actual extent of the improvement has not yet been made plain – full data will come out at Asco in June.
A Chinese regulatory filing will be made at around the same time, and if fruquintinib reaches market it will be sold by Lilly, Chi-Med’s partner for the country. No drugs have been approved in third-line colorectal cancer in China.
Keep on fruqin’
The company is looking at adding other indications, with a pivotal Chinese trial in third-line non-small cell lung cancer, Faluca, due to report in 2018. Fruquintinib is also in a phase II trial in combination with Iressa in the first-line setting for patients with advanced or metastatic NSCLC.
US trials are planned, perhaps combining the small molecule with immuno-oncology approaches, but US approval is not an immediate prospect. However, if and when it should reach the US, fruquintinib could become the first modern drug developed in China to be sold on the global market.
That is if savolitinib does not get there first. Where global efforts for fruquintinib are a comparative afterthought to Chinese marketing, a worldwide view had always been taken for savolitinib. Chi-Med partnered the asset with Astrazeneca in 2011, and while it is still in phase II it is in phase II in the US. No US trials for fruquintinib have yet begun, meaning savolitinib might be in the lead.
While success in Fresco was a necessary first step for Chi-Med’s kinase inhibitor franchise, the real prize will be a win for savolitinib (Chi-Med looks outside its comfort zone, February 21, 2017). Come 2022, the c-Met inhibitor is due to bring Chi-Med royalties worth more than twice the direct sales it can expect from fruquintinib.
|Chi-Med’s TKI pipeline|
|Project||Pharmacology||2022e sales ($m)||2022e royalties ($m)||First launch|
|Fruquintinib*||VEGFr 1-3 kinase inhibitor||132||-||Early 2018|
|Savolitinib**||c-Met kinase inhibitor||-||285||Late 2018|
|Sulfatinib||FGFR1 & VEGFR inhibitor||164||-||Late 2019|
|Epitinib||EGFr tyrosine kinase inhibitor||-||-||-|
|HMPL-453||FGFR 1, 2 & 3 inhibitor||-||-||-|
|*Lilly has China rights; **Astra has global rights except China, where it is co-developing with Chi-Med.|